Depuis plus d’un demi-siècle, aucune des nombreuses étiologies avancées n’a pu répondre à la problématique de la douleur pelvienne chronique chez la femme. L’endométriose peine à elle seule à expliquer la dysménorrhée et la douleur pelvienne de la jeune femme. L’ensemble des auteurs confirme que la présence des lésions d’endométriose ne détermine pas la sévérité de la douleur pelvienne et que la grande majorité des patientes traitées pour endométriose a commencé par une dysménorrhée primaire sévère dès ses premières règles. La dysménorrhée primaire apparaît donc comme une des clés du processus et est à ce titre considérée comme un des précurseurs de l’endométriose. Nous disposons d’un grand nombre de travaux récents et publications robustes démontrant que les jeunes femmes porteuses d’une dysménorrhée primaire de grade 3, sont en situation d’hypersensibilisation pelvienne. La dysménorrhée primaire sévère correspond donc à une douleur nociplastique, dans le cadre d’une sensibilisation centrale, ouvrant à la compréhension d’un syndrome douloureux viscéral utérin, associé aux comorbidités bien connues dans ce groupe de patientes. Un syndrome douloureux utérin peut donc être identifié, au même titre qu’il existe un syndrome douloureux de vessie ou un syndrome de l’intestin irritable. L’hypercontractilité myométriale associée, pousse à le définir plus précisément en syndrome douloureux et hypercontractile utérin (SDHU). Les quatre grands symptômes cliniques qui permettent le diagnostic du SDHU sont détaillés, ainsi que l’association avec les troubles fonctionnels hémorragiques. L’hypercontractilité myométriale s’accompagne d’une hyperpression dans la cavité utérine. Celle-ci s’avère jouer un rôle non négligeable dans l’installation d’une endométriose. La connaissance de ces différents mécanismes physiopathologiques et l’identification du SDHU, offrent des perspectives thérapeutiques qui seront détaillées. En situation d’échec thérapeutique, la toxine botulique répond au cahier des charges du SDHU et les modalités des injections seront précisées.

Objective To develop best practice guidelines under the auspices of the CNGOF (National college of French Gynaecologist Obstetrician) and Convergences PP (Convergences in Pelviperineal Pain) for the management of endometriosis-associated pelvic pain. Method We organised a literature review and a formal group consensus. A multidisciplinary steering committee composed of 14 healthcare professionals and 2 patients association representatives drafted an argument based on literature analysis, resulting in 7 proposed definitions and 59 best practice recommendations. These proposals were then submitted for review by 108 French healthcare professionals from various specialties and professions. The first two rounds of rating were conducted online between June 2024 and November 2024, followed by a final videoconference meeting in January 2025. Results The participation rate was 68% in the first round (74/108) and 76% in the second round (56/74). In total, 3 definitions and 45 best practice recommendations were retained and distributed across 6 sections: 1) Definition; 2) Assessment of chronic pelvic pain associated with endometriosis; 3) Non-pharmacological management; 4) Pharmacological management; 5) Surgical management; 6) Communication, health education, and therapeutic education. Conclusion This formal consensus process has enabled the development of definitions and best practice guidelines to assist healthcare professionals in managing patients suffering from pain associated with endometriosis, thereby promoting better screening, characterization of pain, and therapeutic management.

Objectif Élaborer des conseils de bonne pratique sous l’égide du CNGOF et de Convergences PP pour la prise en charge des douleurs associées à l’endométriose. Méthode Ces conseils de bonne pratique ont été élaborés selon la méthode de consensus d’experts formalisée. Un comité de pilotage pluridisciplinaire composé de 14 professionnels de santé et de deux représentantes d’associations de patientes a rédigé, après analyse de la littérature, un argumentaire et proposé 7 définitions et 59 conseils de bonne pratique. Ces propositions ont été soumises à 108 professionnels de santé français exerçant diverses spécialités et professions. Les deux premiers tours de cotation ont été effectués en ligne entre juin 2024 et novembre 2024, puis une réunion finale en visioconférence s’est déroulée en janvier 2025. Résultats Le taux de participation a été de 68 % au premier tour (74/108) et de 76 % au second (56/74). Au total, 3 définitions et 45 conseils de bonne pratique ont été retenus et ont été répartis en 6 sections : 1) définition ; 2) bilan de la douleur pelvienne chronique associée à l’endométriose ; 3) prise en charge non médicamenteuse ; 4) prise en charge médicamenteuse ; 5) prise en charge chirurgicale ; 6) communication, éducation en santé et éducation thérapeutique. Conclusion Ce consensus formalisé d’experts a permis d’élaborer des définitions et conseils de bonne pratique pour aider la communication des professionnels de santé prenant en charge les patientes souffrant de douleurs associées à l’endométriose, favorisant ainsi un meilleur dépistage, une meilleure caractérisation des douleurs et une meilleure prise en charge thérapeutique.

OBJECTIVE:To develop best practice guidelines under the auspices of the CNGOF and Convergences PP for the management of pain associated with endometriosis. METHOD:We organised a literature review and a formal expert consensus. A multidisciplinary steering committee composed of 14 healthcare professionals and 2 patient association representatives drafted an argument based on literature analysis, resulting in 7 proposed definitions and 59 best practice recommendations. These proposals were then submitted for review by 108 French healthcare professionals from various specialties and professions. The first two rounds of rating were conducted online between June 2024 and November 2024, followed by a final videoconference meeting in January 2025. RESULTS:The participation rate was 68% in the first round (74/108) and 76% in the second round (56/74). In total, 3 definitions and 45 best practice recommendations were retained and distributed across 6 sections: 1) Definition; 2) Assessment of chronic pelvic pain associated with endometriosis; 3) Non-pharmacological management; 4) Pharmacological management; 5) Surgical management; 6) Communication, health education, and therapeutic education. CONCLUSION:This formal expert consensus process has enabled the development of definitions and best practice guidelines to assist healthcare professionals in managing patients suffering from pain associated with endometriosis, thereby promoting better screening, characterization of pain, and therapeutic management.

PUDENDAL NEURALGIAS. Diagnosis of pudendal neuralgia (NP) is clinical, based on the neuropathic type of pain and its topography, in the territory of the terminal branches of the pudendal nerve. It does not require specific paraclinical exploration and perineal electromyography should no longer be systematically proposed. However, a pelvic exploration such as magnetic resonance imaging (MRI) should be requested to rule out any tumoral pathology or anatomical anomaly. The most well-known cause is pudendal nerve entrapment (PNE). This syndrome must meet the five Nantes criteria and include a clear response to local anesthetics injection. Among other causes, known as "non-entrapped" neuropathies, we can mention: stretching neuropathies from dystocic deliveries, direct traumatic neuropathies, metabolic neuropathies of diabetes, herpes infections, chemotherapy-induced neuropathies, toxic neuropathies, and encountered in myofascial syndromes of the buttock or perineal muscles. It is also important to recognize the neuropathic pudendal pain, often poorly systematized and associated with other pelvic pains, from central pelvic hypersensitization. The treatment of PNE benefits from management recommendations (Convergences PP), including a first-line multimodal treatment. In case of failure and after a positive response to the block test, decompression-neurolysis surgery should be considered due to its low aggressiveness, its effectiveness in pain improvement (70 to 80%), and its healing rate (50 to 60%) in properly selected patients. Radiofrequency and cryotherapy, as well as botulinum toxin injections, do not have sufficient evidence and can only be proposed as third-line treatments, within therapeutic protocols, in specialized centers. Neuromodulation and the peri-nerve catheter, connected to a continuous diffusion pump of local anesthetics, are considered in case of failure or recurrence after surgery.

Background and Objective:: Synthetic Mid-Urethral Slings (SMUS) have been widely used with benefit to many women. Complications arise in a small proportion, occurring acutely in the perioperative stage, post-operatively and in a delayed fashion many years after implantation. Clinical trials provide data on selected patients who are as homogeneous as possible. Real world studies rarely provide detail on the denominator population from which the sample originates. Mature clinical quality registries (CQR) provide long term data on a non selected population who have undergone a procedure for a given condition. Near complete case ascertainment is the goal and there are many examples in other clinical areas.Due to the serious and potentially life changing nature of some of the complications that may arise following SMUS, health agencies instigated action on behalf of patients to promote improvements in care. Methods and Limitations:: The International Continence Society (ICS) assembled a multidisciplinary working group to forge this guidance. The working group includes 2 consumer advocates and relevant medical expertise. The management of complications following SMUS placement is discussed and algorithms are provided for each of the common complications of SMUS. The recommendations are based on an expert consensus derived from experience and limited data from a multiple narrative and systematic reviews of the literature. Due to a retrospective design, low cohort numbers, short follow-up and inconsistent definitions, all the studies were at high risk of bias (Figure 1). Key Findings and Conclusions:: This overview of SMUS complications commissioned by the ICS aims to provide background literature and algorithms for management of common problems that may present, though it is not exhaustive. Problems such as recurrent urine infection and overactive bladder may have their root cause in an obstructive SMUS. The temporal link between sling implantation and onset of symptoms is not always evident and patients are not always aware that an SMUS was implanted as part of a pelvic floor procedure. Clinicians need to be assiduous in their history taking and physical examination to determine the likely root cause using imaging or other tests judiciously. Multi-disciplinary teams (MDT) are required particularly where chronic pain has developed

VULVODYNIAS. Vulvodynia is a chronic pain. The distinction between so-called "provoked" vulvodynia and "spontaneous" vulvodynia allows a diagnostic and therapeutic orientation. "Provoked" vulvodynia responds to the mechanisms of hyperalgesia encountered in hypersensitization. The model is provoked vestibulodynia. The model of "spontaneous" vulvodynia is pudendal nerve neuralgia, whose mechanism is neuropathic pain. Other types of vulvodynia are due to peripheral sensitization or integrated into the central pelvic hypersensitization syndrome and the vulvodynia of myofascial syndromes and the clitorodynia. Finally, a specific place will be given to the persistent genital arousal disorder (PGAD). Understanding vulvodynia requires a good knowledge of the anatomy and the mechanisms of peripheral and central sensitization.

OBJECTIVE:To assess the cost-effectiveness sand the budgetary impact of the combination of botulinum toxin (BT) + conventional treatment (CT) (hormonal treatments + analgesics) compared with CT alone in patients suffering from severe dysmenorrhoea, using a Markov model. METHODS:A Markov model was developed to estimate, from the perspective of French Health Insurance (HI), the cost effectiveness and the budgetary impact of BT+CT compared with CT alone. The main health states in the model were based on Visual Analogue Scale (VAS) scores and expert opinion. All model parameters were derived from a cohort of patients treated for 12 months at the Centre de Recherche de la Santé et de la Femme (CRSF) for severe dysmenorrhoea in 2021. A Cost-Utility Analysis (CUA) was carried out to assess the quality of life of patients, crucial in this context, in which the direct healthcare costs were considered in and Budget Impact Analysis (BIA). The main decision-making criteria were the Incremental Cost-Utility Ratio (ICUR) for the CUA and the net impact for the BIA. Deterministic and probabilistic univariate sensitivity analyses were performed to assess the robustness of our results. RESULTS:Over the 1-year time horizon (main analysis), the costs and quality-adjusted life year (QALY) of BT+CT versus CT alone were equal to €1895.65 vs €3055.20 and 2.03 QALYs vs 1.23 QALYs, respectively. Consequently, the ICUR equalled -€1651.5/QALY, which shows that, although the initial costs of BT are higher than those of CT, the reduced follow-up costs associated with the long-term efficacy of BT make it the most effective and economically dominant option at 1, 5 and 10 years. Sensitivity analyses show that 100 % of Monte Carlo iterations are below the willingness-to-pay threshold of €30,0001/QALY, making BT+CT an efficient strategy that could be adopted and reimbursed. CONCLUSION:In the absence of a reference treatment for the management of severe dysmenorrhoea, BT+CT offering an improvement in quality of life, as well as a reduction in follow-up costs. It is therefore the most cost-effective strategy over 10 years.

BACKGROUND:Pudendal neuralgia caused by entrapment syndrome (PNE) is an underdiagnosed condition with severe quality of life (QoL) impact. In cases unresponsive to medical treatment, a minimally invasive surgical approach, such as laparoscopic surgery, is preferred, particularly in patients presenting central sensitisation (CS) and myofascial syndrome (MS). Although the procedure has proven to be safe and feasible, limited studies examinate its impact on QoL. OBJECTIVES:This retrospective observational study was conducted at the Résilience Center, Axium Clinic, Aix-en-Provence, France, with the objective to assess QoL improvement and pain relief in PNE patients treated with laparoscopic pudendal neurolysis, focusing on those with CS. Secondary objectives included assessing the occurrence of surgical complications and improvements in urinary, intestinal and sexual functions. METHODS:The study involved 147 patients operated from January 2018 to June 2023. The patients' status was evaluated using validated surveys at the preoperative consultation, at 4-6 weeks, 6-12 months and 3 years post-surgery for those operated up to 2020. RESULTS:The laparoscopic approach resulted safe and effective, showing significant improvements in VAS score (χ2:132.4,df=3,p < 0.001), QoL (χ2:133,df=3,p < 0.001), urinary (χ2:26.3,df=3,p < 0.001), intestinal (χ2:26.3,df=3,p < 0.001), and sexual functions (χ2:8.5,df=3,p < 0.001). MS and CS patients demonstrated diminished improvement scores. The implementation of a multidisciplinary approach significantly improved outcomes within these subgroups. A preoperative VAS score >8 was a significant risk factor for surgical failure (OR 19.2 for PGI, 14.2 for QoL, p < 0.001). CONCLUSION:A multidisciplinary approach aimed at reducing VAS score below 8 before surgery is recommended to optimize outcomes, particularly in CS patients.

Background:: Sacrohysteropexy and sacrocolpopexy are established treatments of uterine or vaginal vault prolapse respectively and involve insertion of mesh abdominally, often using permanent sutures and fixation devices. Complications following these procedures may be serious, and there is lack of evidence about long-term functional outcomes in terms of pain, dyspareunia and development of lower urinary tract and bowel symptoms. Objective:: A non-systematic review of the available literature was performed and recommendations on assessment and management were developed by expert consensus. Conclusion:: The current evidence is limited in quantity and quality, and recommendations on assessment management of mesh-related complications were made by experts in the field. Assessment and treatment of complications following abdominally placed mesh for pelvic organ prolapse will often require a multidisciplinary approach. Assessment may require EUA, and/or cystourethroscopy, sigmoidoscopy, and laparoscopy. MRI is the most useful imaging modality. Surgery to remove mesh carries a risk of urinary tract and bowel injury, as well as development of recurrent pelvic organ prolapse. A joint decision between the surgeon and the patient should be made before embarking on a partial removal of mesh; removal of all the mesh may be a better option albeit with higher risk of surgical complications. Complete removal of mesh and tacks or sutures from the sacral attachment may not be possible and is associated with risk of major haemorrhage.

Abstract Objectives: To evaluate the efficiency of botulinum toxin (BT) for the management of severe dysmenorrhoea, after failure of conventional treatments (CT) (hormonal treatments + analgesics) by an incremental cost-effectiveness ratio (ICER), from the perspective of the French Health Insurance (HI). Methods: This was a retrospective study (Before and After comparison) based on the patients' medical records (n=20). Data on health care consumption and quality of life were collected prospectively during the Before phase, which corresponds to the CT period, and the After phase, which corresponds to the period after the addition of BT injection. The data were analysed over a time horizon of one year, according to the perspective of the French HI. In the main analysis, total average costs included direct and indirect costs. Efficiency was assessed using the incremental cost-effectiveness ratio (ICER). The innovative strategy was considered efficient at a threshold of 30,000 € / QALY. A probabilistic sensitivity analysis using the Monte Carlo method was performed to take into account the uncertainty around the ICER related to sampling fluctuations, as well as a deterministic sensitivity analysis to evaluate the sensitivity of the ICER to the model hypotheses. Results: The results of the main analysis indicate, from the perspective of the French HI system, that the combination of TB + CT with an ICER: -981.98€ / QALY gained [-2187.48 ; 897.46], was the most efficient strategy at the 30,000€ efficiency threshold (dominant strategy). The combination of BT + CT: 714.82€ +/- 336.43€ was less costly than CT alone: 1104.16€ +/- 227.37€. The main cost item in our study was the cost of daily allowances. In addition, BT was more efficient than CT in terms of QALYs gained. Therefore, the use of BT in addition to CT is an efficient and beneficial strategy that could be considered for the management of dysmenorrheic patients. Conclusion: This study showed that, for patients with severe dysmenorrhea who are not adequately managed with CT alone, BT + CT appeared to be clinically effective and cost effective in the perspective of the French HI.

OBJECTIVE:To evaluate quality of life (Qol), pain level and medical consumption before and after uterine botulinum toxin (BT) injections in severe dysmenorrhea, dyspareunia and chronic pelvic pain. METHODS:This was a before and after study using the database of a pilot study (Open-label non comparative study, on 30 patients, with severe dysmenorrhoea in therapeutic failure) assessing efficacy and cost of uterine injection of BT in women with chronic pelvic pain after failure of conventional treatment (hormonal and analgesics) (CT). Main clinical outcome: Patient Global Impression of Improvement (PGI-I), EuroQol health-related QoL (EQ-5D-5L), EuroQol-visual analogue scale (EQ-VAS), Female Sexual Function Index (FSFI), utility measure of health-related quality of life (also called health state preference values), cost and of health care consumption were collected prospectively and analysed in the two phases (before and after). The two timepoints were 12 months before uterine BT injection, when the patient had been receiving CT, and 12 months after uterine BT injection. RESULTS:Median visual analogue scale scores were significantly improved by BT regarding the patients' main source of pain (31.6 vs 80.55; p < 0.00001). We also noted a significant reduction in the proportion of patients who reported dyspareunia [15 (75%) vs 3 (15%) patients, p = 0.001] and pain during menstruation (p < 0.0001). The PGI-I scale showed a significant increase in the proportion of patients who were satisfied with their treatment after receiving the BT injection. The injection of BT was frequently associated with increase in QoL and a reduction in health care consumption, and cost: 714.82 €+/- €336.43 (BT) versus 1104.16 €+/- €227.37 (CT), which could result in substantial savings approximately (389,34€) per patient. CONCLUSION:This study revealed the clinical effectiveness of BT injections on dysmenorrhea, chronic pelvic pain as well as reduction of cost and health care consumption, in our population, which is innovative since no standard of treatment exists in this domain.

Introduction and aims of the study: Severe dysmenorrhea and chronic pelvic pain (CPP) from uterine origin may be followed by psycho-social consequences and professional absenteism. Despite a negative magnetic resonance imaging and laparoscopy, current available treatments (analgesics, anti-inflammatory drugs and hormones) are ineffective with low quality of life gains. As published previously, injections of botulinum toxin (BT) type A under hysteroscopy into uterine myometrium revealed significant decrease of patient-reported symptoms and improvement of global quality of life scores at 8 and 12-week post-injection. The aims of this study are to evaluate clinical and cost-effectiveness of BT use for severe dysmenorrhea/CPP after treatment failure. Methods: Phase-III randomized monocentric controlled trial comparing BT versus placebo among 100 participants. Randomization will be centralized. Study investigators, analysis team, and subjects will remain blinded. Participants will be informed and will sign a written informed consent. Data will be collected and registered in a secure electronic platform before enrollment, at inclusion, 8-week and 4-month follow-up. Main clinical outcome: Patient Global Impression of Improvement. Secondary clinical outcomes: Health-Related Quality of Life (HRQoL) by Endometriosis Health Profile, Generic HRQoL EQ-5D-3L, Female Sexual Function Index, dysmenorrhea and dyspareunia numerical rating scale, pain visual analogue scale, side effects, drug tolerance, surgical complications, global patient satisfaction. Effectiveness and costs outcomes: quality-adjusted life years (QALYs), direct and indirect costs, net social benefit, incremental cost-effectiveness ratios. Discussion: This study will provide the most reliable evidence on the effectiveness of a novel therapy for patients suffering from severe dysmenorrhea and CPP from uterine origin, in the event of standard therapeutic failure. The health economic evaluation will give evidence to guide collective decision-making on marketing authorization for this clinical indication. Conclusions: Evidence-based clinical and cost-effectiveness of BT will guide the proposal and implementation of a new treatment for severe dysmenorrhea and CPP from uterine origin.

BACKGROUND:Since the development and publication of diagnostic criteria for pudendal nerve entrapment (PNE) syndrome in 2008, no comprehensive work has been published on the clinical knowledge in the management of this condition. The aim of this work was to develop recommendations on the diagnosis and the management of PNE. METHODS:The methodology of this study was based on French High Authority for Health Method for the development of good practice and the literature review was based on the PRISMA method. The selected articles have all been evaluated according to the American Society of Interventional Pain Physicians assessment grid. RESULTS:The results of the literature review and expert consensus are incorporated into 10 sections to describe diagnosis and management of PNE: (1) diagnosis of PNE, (2) patients advice and precautions, (3) drugs treatments, (4) physiotherapy, (5) transcutaneous electrostimulations (TENS), (6) psychotherapy, (7) injections, (8) surgery, (9) pulsed radiofrequency, and (10) Neuromodulation. The following major points should be noted: (i) the relevance of 4+1 Nantes criteria for diagnosis; (ii) the preference for initial monotherapy with tri-tetracyclics or gabapentinoids; (iii) the lack of effect of opiates, (iv) the likely relevance (pending more controlled studies) of physiotherapy, TENS and cognitive behavioural therapy; (v) the incertitudes (lack of data) regarding corticoid injections, (vi) surgery is a long term effective treatment and (vii) radiofrequency needs a longer follow-up to be currently proposed in this indication. CONCLUSION:These recommendations should allow rational and homogeneous management of patients suffering from PNE. They should also allow to shorten the delays of management by directing the primary care. SIGNIFICANCE:Pudendal nerve entrapment (PNE) has only been known for about 20 years and its management is heterogeneous from one practitioner to another. This work offers a synthesis of the literature and international experts' opinions on the diagnosis and management of PNE.

Background: Acute dysmenorrhoea in women which has been shown to be anatomically negative for endometriosis is a very common condition. It is frequently associated with Chronic Pelvic Pain (CPP) from uterine origin, including painful uterine contractions and deep dyspareunia. We call this association Painful Uterine Syndrome (PUS). Search strategy: In these women in failure of the usual treatments, we proposed a new treatment, with Uterine Toxin Botulinic injections (BTX) under hysteroscopy, as a compassionate option, among women in severe pain and therapeutic failure. Indeed, increased uterine contractility has been confirmed using cine magnetic resonance imaging in patients with acute dysmenorrhea and PUS. These findings, associated with the hypothesis of a possible uterine sensitization on the same model as irritable bowel syndrome (IBS) or painful bladder syndrome (PBS), led to the application of botulinum toxin (BTX) injections under hysteroscopy of the uterine myometrium in this indication. Material and methods: In 2018, we conducted an open-label non comparative study, on 30 patients, with severe dysmenorrhea and PUS in therapeutic failure situation. All women had failure of usual treatments, with painkillers, anti-inflammatory drugs, contraceptive pill, menstrual suppressant therapy and a negative MRI and laparoscopy. T he BTX units (200 IU of Incobotulinum-toxin A) were evenly distributed in the anterior and posterior myometrial wall under hysteroscopic control. Patients were reviewed between 8 and 12 weeks after BTX injections and then, at 6 months. Main results: Median VAS scores were significantly improved at 8-12 weeks follow up for dysmenorrhoea, deep dyspareunia, and pelvic pain outside of menstruation. Quality of life scores all improved dramatically. No major side effect has been reported in this pilot study. At 6 months, 12 patients (40 %), were given new injections for pain reccurence. But 14 patients (47 %), were still improved and did not require repeat injection at that time. 4 patients, were improvement was not significant, did not ask for repat BTX injections. These patients were all positive for Pelvic Sensitization criteria. Conclusions: Uterine BTX injection could be a very interesting therapeutic option in women with acute dysmenorrheoa and PUS in therapeutic failure. Only long-term randomised studies will be able to confirm that BTX injections are useful as a treatment for this condition. The randomised long-term study, Uteroxine, will shortly release its results. (c) 2020 Elsevier Masson SAS. All rights reserved.

BACKGROUND:Many studies have demonstrated a link between pelvic floor myofascial syndromes and chronic pelvic pain. Botulinum toxin has been extensively used for several years in the field of pain, especially due to its action on muscle spasm. However, the efficacy of botulinum toxin in the context of chronic pelvic pain remains controversial. OBJECTIVES:This multicentre, randomized, controlled, double-blind study was designed to compare the efficacy of botulinum toxin and local anaesthetic (LA) injection versus LA injection alone for pelvic floor myofascial syndrome and chronic pelvic pain. METHODS:According to the number of painful trigger points detected on physical examination, patients received from 1 to 4 injections of botulinum toxin with LA (BTX) or LA alone. The primary endpoint was Patient Global Impression of Improvement (PGI-I) score on day 60 after infiltration. Secondary endpoints were pain intensity, number of painful trigger points on palpation, analgesic drug consumption and quality of life. RESULTS:We included 80 patients, 40 in each group. This study failed to demonstrate a significant difference between the 2 groups on day 60 in the primary endpoint or secondary endpoints (PGI-I score≤2=20% [LA] versus 27.5% [BTX], P=0.43). However, both groups showed significant alleviation of global pain. CONCLUSION:This study does not justify the use of botulinum toxin in the context of chronic pelvic pain with myofascial syndrome but does justify muscle injections with LA alone. ClinicalTrials.gov: NCT01967524.